Debashish Roy, Ph.D. Email & Phone Number

Durham, North Carolina, US

• Proficient in the GLP-compliant environment's analytical and molecular biology techniques.
• Assisted in preparing and reviewing study reports supporting regulatory documentation related to product development, especially CMC sections of the IND filings and BLA enabling studies towards submission, ensuring.
• Managed and reviewed regulatory compliance documentation, test protocols, and validation documents, ensuring compliance with both internal and external regulatory expectations.
• Authored formulation and stability protocols for biologics drugs aligned with regulatory requirements (e.g. FDA, ICH).
• Participated in internal regulatory inspection readiness, addressing regulatory gaps and driving corrective and preventive actions to maintain compliance with industry regulations and quality standards.
• Worked in collaboration with quality assurance (QA), core facilities, and analytical development teams to ensure all stages of product development complied with regulatory standards.

Winston-Salem, NC, US

• Five plus years’ hands-on work experience with Capillary electrophoresis and chromatography techniques; method development, optimization and validation.
• Developed ssDNA aptamer sensor for the toxicological screening of controlled/toxic compounds in the patient urine sample by way of Capillary electrophoresis
• Optimized Capillary electrophoresis-based DNA aptamer-target separations employing fluorescent carbon nanoparticles
• Identified and isolated target-specific aptamer using Next-generation sequencing (NGS)
• Performed statistical analysis of spectroscopy data using R for data interpretation and visualization
• Collaborated with researchers in chemistry department and our industry research partner

Columbia, MD, US

• Performed method development and validation for pain medications on Agilent Technologies, Waters, Thermo Scientific, and SCIEX LC/MS/MS platforms.
• Review, tabulate, and conduct statistical analysis and data modeling using SAS and R programming languages on research and production data.
• Developed and validated methods for pain medications
• Developed method for analyzing illicit drugs found in patient samples.
• Conduct experiments to assess utility of novel experimental technologies
• Develop Statistical Models of Medication Data to discern drug distribution patterns, and enhance patient care

Uppsala, Uppsala Län, SE

• Experienced in studying antimicrobial resistance in Mycobacterium tuberculosis and Staphylococcus aureus against synthesized medicinal products, utilizing BSL-2 and -3 lab environments in collaboration with a.
• Studied vector-borne illness involving dengue fever and epidemiology of Zika virus among Asian population.
• Research focused on synthesizing stable and minimalized antimicrobial plant peptides (AMP) and assessing their activity via bioassay.
• Engineered and synthesized peptide variants for the diagnosis of rheumatoid arthritis.
• Performed antimicrobial peptide and protein purification and identification using LC-MS/MS

Dhaka, BD

• Performed in formulation development for oral (tablet), injectable, and inhalation (MDI) drugs.
• Designed and conducted experiments for assay procedure development and validation on GC, LC MS/MS, UPLC, etc., dissolution, and stability studies.
• Assisted in preparing and reviewing regulatory documents, performed internal audits, and writing standard operating procedures (SOPs) following cGMP guidelines.
• Maintained analytical instruments by routine maintenance, troubleshooting, calibration.

BD

• Performed in formulation development for oral (tablet, capsules), topical, and injectable drugs.
• Designed and conducted experiments for assay method development and validation on GC, LC-MS/MS, UPLC, KF, AAS, etc., dissolution and stability studies.
• Conducted raw materials analysis to determine the purity and quality of API
• Assisted in preparing and reviewing regulatory documents, performed internal audits, and writing standard operating procedures (SOPs) following cGMP and GLP guidelines.
• Maintained analytical instruments by routine maintenance, troubleshooting, calibration.

Basel, Baselstadt, CH

• Developed multi-particulate dosage forms using various manufacturing techniques
• Prepared work model and characterized developed formulation for in-vitro performance
• Participated in globally recognized GMP and GLP training program

Regulatory Affairs

Doctor Of Philosophy - Phd, Bioanalytical Chemistry

Master'S In Medical Science, Infection Biology

Bachelor Of Pharmacy (Honors), Pharmacy